Details for Patent: 9,108,002

Which drugs does patent 9,108,002 protect, and when does it expire?

Patent 9,108,002 protects OZEMPIC and SAXENDA and is included in two NDAs.

Protection for SAXENDA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has fourteen patent family members in eleven countries.

Summary for Patent: 9,108,002

Title:	Automatic injection device with a top release mechanism
Abstract:	The present invention relates to a handheld mechanical injection device by which set doses of a liquid medicament can be injected from a medical reservoir. The medicament is expelled through an injection needle by release of a power reservoir in the device, the power reservoir being fully or partially released by actuation of a user operable release member being positioned at or near an upper end of the injection device, the upper end being that end of the injection device which is opposite the injection needle.
Inventor(s):	Markussen; Tom Hede (Bagsv.ae butted.rd, DK)
Assignee:	Novo Nordisk A/S (Bagsvaerd, DK)
Application Number:	13/326,738
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,108,002
Patent Claim Types: see list of patent claims	Device;

United States Patent 9,108,002: A Detailed Analysis of Scope, Claims, and Patent Landscape

Overview of the Patent

United States Patent 9,108,002, issued to Novo Nordisk, is a crucial patent in the pharmaceutical sector, particularly protecting the drugs Ozempic (semaglutide) and Saxenda. Here, we delve into the scope, claims, and the broader patent landscape surrounding this patent.

Patent Protection and Expiration

The patent 9,108,002 is part of a comprehensive patent portfolio that protects Ozempic and Saxenda. It is set to expire on January 20, 2026, along with several other related patents[1][4].

Claims and Scope

Drug Protection

This patent specifically protects the formulation and use of semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist used in the treatment of type 2 diabetes and, in the case of Saxenda, for weight management[4].

Specific Claims

The patent includes multiple claims that cover various aspects of the drug and its delivery mechanism. For example:

• Claims related to the formulation of semaglutide.
• Claims directed to the injection device and its components, such as dose delivering mechanisms and feedback signals[2][5].

Injection Device Mechanisms

One of the key aspects of this patent is the protection of injection devices that provide audible feedback signals to the user at the end of the injection of a set dose. This feature is critical for ensuring accurate dosing and user compliance[2].

Patent Family and International Coverage

Patent 9,108,002 is part of a larger patent family with protection extended to several countries, including Australia, Brazil, Canada, and Denmark, among others. This international coverage ensures that Novo Nordisk's intellectual property is protected globally[4].

Litigation and ANDA Filings

The patent has been involved in several legal disputes, particularly with generic drug manufacturers. For instance, Mylan Pharmaceuticals has filed Abbreviated New Drug Applications (ANDAs) that have led to patent infringement lawsuits. These lawsuits often involve multiple patents, including 9,108,002, and are part of the broader litigation landscape surrounding Ozempic and Saxenda[1][5].

Generic Challenges

Generic manufacturers like Mylan have challenged the validity and enforceability of these patents, including 9,108,002, as part of their ANDA filings. These challenges are common in the pharmaceutical industry and can significantly impact the market dynamics and patent landscape[1][5].

Patent Scope Metrics

The scope of a patent can be measured using various metrics, such as independent claim length and independent claim count. These metrics can provide insights into the breadth and clarity of the patent claims. For instance, narrower claims are often associated with a higher probability of grant and a shorter examination process, which could be relevant in understanding the strategic positioning of patent 9,108,002[3].

Impact on Innovation and Market

The protection afforded by patent 9,108,002 and its related patents has significant implications for innovation and market competition. By extending the exclusivity period for Ozempic and Saxenda, Novo Nordisk can continue to invest in research and development without immediate generic competition. However, this also means that generic alternatives, which could be more affordable, are delayed from entering the market[4].

Conclusion

United States Patent 9,108,002 is a pivotal patent in the pharmaceutical industry, safeguarding the intellectual property of Novo Nordisk's key drugs, Ozempic and Saxenda. Its claims and scope are meticulously defined to cover critical aspects of the drug formulation and delivery mechanisms. The ongoing litigation and ANDA filings highlight the complex patent landscape and the strategic battles in the pharmaceutical sector.

Key Takeaways

• Patent Expiration: The patent is set to expire on January 20, 2026.
• Drug Protection: It protects the formulation and use of semaglutide.
• International Coverage: Part of a larger patent family with global protection.
• Litigation: Involved in several patent infringement lawsuits related to ANDA filings.
• Impact on Market: Extends exclusivity for Ozempic and Saxenda, affecting market competition and innovation.

FAQs

Q: What drugs are protected by United States Patent 9,108,002? A: The patent protects Ozempic (semaglutide) and Saxenda.

Q: When does the patent 9,108,002 expire? A: The patent is set to expire on January 20, 2026.

Q: What are the key claims of the patent? A: The patent includes claims related to the formulation of semaglutide and the injection device mechanisms, including audible feedback signals.

Q: Is the patent part of an international patent family? A: Yes, it is part of a larger patent family with protection in several countries.

Q: What is the significance of the patent in the pharmaceutical industry? A: It extends the exclusivity period for Ozempic and Saxenda, impacting market competition and innovation.

Sources

1. In Re: Ozempic (Semaglutide) Patent Litigation - Justia Dockets.
2. United States District Court - RPX Insight.
3. Patent Claims and Patent Scope - SSRN.
4. Patent 9,108,002 - DrugPatentWatch.
5. OZEMPIC (SEMAGLUTIDE) MDL No. 22-MD-3038 (CFC) - RPX Insight.

Drugs Protected by US Patent 9,108,002

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-001	Dec 5, 2017		RX	Yes	Yes			Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-004	Oct 6, 2022		RX	Yes	Yes			Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-002	Apr 9, 2019		RX	Yes	Yes			Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-003	Mar 28, 2022		RX	Yes	Yes			Y
Novo	SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014		RX	Yes	Yes					Y

Foreign Priority and PCT Information for Patent: 9,108,002

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Denmark	2005 00113	Jan 21, 2005

International Family Members for US Patent 9,108,002

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2006207744
Brazil	PI0606607
Canada	2594764
China	100571805
China	101107031